Senior Specialist, Pharmacovigilance Epidemiology & Risk Management

Roles & Responsibilities
• Screen scientific and medical literature using internal search tools and external databases
• Classify and track safety-relevant literature references
• Manage internal literature ordering and tracking processes
• Enter literature-derived cases into the safety database
• Prepare standard safety reporting forms including CIOMS I, MedWatch, and XML files
• Complete case documentation in accordance with pharmacovigilance standards
• Download, review, and distribute client-specific ICSRs from EMA’s MLM service
• Perform duplicate checks against updated literature cases in the EMA MLM system
• Allocate work within internal systems and provide system access and training to team members
• Conduct quality checks for MLM-related pharmacovigilance activities
• Support Business Continuity Planning activities in coordination with management
• Act as primary point of contact for client and project-related coordination

Qualification
• University degree in Life Sciences or related discipline

Experience
• Minimum 3 years of hands-on experience in Pharmacovigilance
• Strong exposure to Medical Literature Monitoring activities

Skills
• Sound knowledge of pharmacovigilance processes and regulatory requirements
• Experience with safety databases and ICSR handling
• Strong written and verbal communication skills
• Ability to identify issues and propose effective solutions
• High attention to detail and documentation accuracy
• Ability to work collaboratively in a global team environment

About the Organization
Cencora is a global healthcare organization dedicated to creating healthier futures by improving access to pharmaceutical care and safety worldwide. Through its affiliate PharmaLex India Private Limited, Cencora delivers expert regulatory and pharmacovigilance services, supporting life sciences companies in ensuring patient safety and regulatory compliance across global markets.